Duns Number:831375089
Device Description: Latex Underglove, PF, Size 7.5, PairColor Green50pair/box, 4bx/case
Catalog Number
44275
Brand Name
PremierPro Surgeons Glove
Version/Model Number
44275
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
049c205a-22d6-4474-82de-1a430304215b
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 11, 2019
Package DI Number
20811220031088
Quantity per Package
200
Contains DI Package
10811220031081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cs
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 486 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |
U | Unclassified | 1 |